Resveratrol in Patients With Non-alcoholic Fatty Liver Disease

NCT01464801 | Completed DMC

• 1 other identifier: LIRMOI 3
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common in the Western world and strongly associated with obesity. No known effective treatment is known. From animal studies, it is known that the compound resveratrol perhaps has the potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a food supplement though the precise effects are unknown. This project focuses on the effect of Resveratrol on fatty liver disease. The researchers plan to investigate the effects of Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.

Conditions

Fatty Liver

Keywords

Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Resveratrol; Human study

Outcome Measures

Primary Outcomes (1)

• Change in hepatic steatosis and inflammation

  Changes in hepatic and inflammatory markers ind the blood such as ALT, hs-CRP, TNFa Changes in hepatic fat content, assessed by MR spectroscopy Changes in hepatic steatosis and inflammation, assessed histologically Changes in the expression of proteins in the relevant inflammatory pathways, assessed by gene expression studies

  6 months

Secondary Outcomes (1)

• Assessment of tolerability and side-effects

  6 months

Study Arms (2)

Resveratrol

EXPERIMENTAL

Subjects are given resveratrol 500 mg 3 times daily for 6 months.

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

Subjects are given Placebo tablets 3 times daily for 6 months.

Dietary Supplement: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Tablet Resveratrol 500 mg 3 times daily for 6 months

Resveratrol

Placebo DIETARY_SUPPLEMENT

Tablet Placebo 3 times daily for 6 months

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALT ≥70 U/L for men and ≥45 U/L for women
• steatosis of the liver, assessed by ultrasonography
• one of the following:
• waist circumference ≥102 cm for men and ≥88 for women
• hypertension: BP ≥130/80 mmHg
• raised triglycerides ≥1,7 mmol/L
• reduced HDL cholesterol ≤1.0 mmol/L
• BMI ≥ 25 kg/m²

You may not qualify if:

• weight \> 130 kg
• comorbidity such as diabetes, cancer, metabolic or coagulation disorder, or significant liver-, heart- or kidney disease
• MRI contraindication
• treatment with glucocorticoids or methotrexate
• alcohol intake \>20g/daily for men and \>12 for women

Sponsors & Collaborators

• University of Aarhus: lead
• The Ministry of Science, Technology and Innovation, Denmark: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University Hospital, Dept. of Hepatology and Gastroentology

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Henning Grønbæk, MD, PhD

  Department of Hepatology and Gastroentology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: November 4, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 15, 2015

Record last verified: 2013-08

Locations

DK (1)